It may have been a short holiday week, but there was plenty of news on the CRISPR front. In the ongoing battle for rights to the landmark gene editing technology, the faction led by the University of California appealed the U.S. decision in favor of the Broad Institute.
Elsewhere, Bristol-Myers Squibb flipped assets, a top dealmaker made an unexpected tack into the perilous waters of Alzheimer’s drug development, and the SEC cracked down on stock pumping schemes. Let’s round it all up.
TO SCREEN, OR NOT TO SCREEN
—The influential US Preventive Services Task Force slightly shifted its position on the “PSA” test that screens men for prostate cancer. Since 2012 the task force has discouraged all use of the test, giving it a “D” grade. The task force changed its grade this week to “C”—potential benefits likely remain small, but men ages 55 to 69 should discuss the test with their doctors. A media watchdog took the mainstream press to task for mischaracterizing the shift. The task force maintained its “D” grade for men 70 and older.
—The idea of screening healthy people for early signs of cancer has captured the attention of people in healthcare, tech, and finance, with new companies racing to detect the slightest traces of cancer in blood samples. Buzzfeed recently spoke to doctors and scientists who are skeptical of the idea; the attitudes were similar a year ago, soon after well-funded liquid biopsy startup Grail launched.
CRISPR WARS, HUNG RETURNS
—Who owns the breakthrough genome-editing system CRISPR-Cas9? The fight in the U.S. continues, as a group led by the University of California appealed the recent decision of a special arm of the U.S. patent office that upheld the rights granted to the Broad Institute. Across the pond, the European Union has granted key patents to the UC group, which includes the University of Vienna and French microbiologist Emmanuelle Charpentier. Broad officials say it is “widely expected” that “many parties” will oppose the EU patents.
—Eight months after selling Medivation to Pfizer for $14 billion, David Hung re-emerged this week as the CEO of Axovant Sciences (NASDAQ: AXON), which is expecting crucial Phase 3 data for its Alzheimer’s drug intepirdine (aka RVT-101) this fall. SEC documents showed Hung has promised to invest $10 million in Axovant’s upcoming round of financing, and he will receive six million stock options, many of which are tied to the outcome of the intepirdine trial.
SHOULD WE TALK ABOUT THE GOVERNMENT
—The Securities and Exchange Commission charged 27 individuals and biotech companies with illegal stock promotion tactics. The SEC alleged that ImmunoCellular Therapeutics, Lion Biotechnologies, and Galena Biopharma hired writers to pump their stocks with bullish articles while falsely disclosing they weren’t being paid. 17 of the defendants have settled, while litigation continues against the remaining 10. Here’s more at TheStreet.com.
—The FDA will evaluate the “organ-on-a-chip” system from Boston startup Emulate as a potential alternative to using animals to test for toxicity in foods, cosmetics, and drugs.
—After two decades, San Diego drug developer Neurocrine Biosciences (NASDAQ: NBIX) has received its first drug approval. The FDA green-lighted valbenazine (Ingrezza) to treat involuntary facial movements known as tardive dyskinesia, often a side effect of prolonged use of anti-psychotic medications.
TRIALS AND DATA
—OncoMed Pharmaceuticals (NASDAQ: OMED) got a double dose of bad news, as one of its stem cell drugs failed a Phase 2 trial in pancreatic cancer, and Bayer decided against an option to two of its other drugs. Shares fell more than 40 percent.
—Bay Area firm Geron (NASDAQ: GERN) said it would continue its cancer partnership with Johnson & Johnson (NYSE: JNJ), signed in 2014. After reviewing data from studies of Geron’s imetelstat, the drug giant delayed a decision to commit major resources. Geron shares were up 25 percent on the news before settling back down.
DEALS, FINANCINGS, & IPOS
—In separate deals, Bristol-Myers Squibb (NYSE: BMY) sold two experimental drugs to Biogen (NASDAQ: [[tkcker:BIIB]]) and Roche for a combined $470 million up front. The two drugs are remnants of Bristol’s past buyouts of iPierian and Adnexus Therapeutics, as well as a strategy the company is no longer pursuing.
—There are no drugs approved for hearing loss, but an increasing focus on investments in new experimental therapies. MIT and Harvard spinout Frequency Therapeutics is the latest example, grabbing a $32 million Series A round in an effort to restore hearing loss.
—Boston-based VC firm SV Life Sciences closed a $400 million fund, its sixth, and changed its name to SV Health Investors “to better reflect the firm’s longstanding strategy and multi-sector focus,” it said in a statement.
—Lyndra, a drug delivery startup spun out of the MIT labs of Bob Langer, raised $23 million in a Series A round of financing. The Watertown, MA-based company plans to develop oral formulations of long-acting drugs.
—Kalamazoo, MI-based biotech Octeta Therapeutics raised $40 million and changed its name to Cirius Therapeutics. The company is studying a potential treatment for nonalcoholic steatohepatitis and fibrosis, conditions that cause severe liver damage.
—NYU Langone Medical Center’s office of therapeutics alliances, an initiative to advance drug discovery projects from the center’s labs, has formed Nybo Therapeutics to go after pancreatic cancer. The developer will function as a subsidiary of Boston’s PureTech Health.
—Ex-Teva Pharmaceutical and Bristol-Myers Squibb executive Jeremy Levin is readying an IPO pitch for his new firm, New York startup Ovid Therapeutics. Ovid takes drugs originally discovered in pharma and academia and develops them for rare brain diseases.
—This week we unveiled the program for our May 11 life sciences event, “What’s Hot in Boston Biotech.” Check out the agenda here—we’ll be tackling broad topics like the opioid crisis, immigration, the rise of influence of patient advocacy and much more.
Alex Lash and Frank Vinluan contributed to this report